MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® VIATORR® TIPS ENDOPROSTHESIS WITH CONTROLLED EXPANSION; SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS

Model Number PTB8107275

Device Problems Difficult to Open or Close (2921); Unintended Movement (3026)

Patient Problem Foreign Body Embolism (4439)

Event Date 06/02/2022

Event Type  malfunction  

Manufacturer Narrative

W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Event Description

It was reported the physician selected a gore® viatorr® tips endoprosthesis with controlled expansion for a pre-operative tips (transjugular intrahepatic portosystemic shunt) prior to colon cancer resection.The tract was pre-dilated and the bare metal stent was deployed without issue.After the device was situated, the physician attempted to deploy the covered portion of the endoprosthesis.Fluoroscopy showed that the stent started to expand; however, the deployment line became stuck and the last 2cm of the device in the hepatic vein did not deploy.The deployment line was pulled again but the stent was pulled back into the heart.At this point, the physician upsized to a 16mm sheath and attempted to retrieve the stent with a snare.This attempt was unsuccessful and the physician switched to biopsy forceps to remove the device.The stent began to unravel and was removed in several pieces.The entire stent was removed with no adverse effect to the patient.A second gore® viatorr® tips endoprosthesis with controlled expansion was then successfully implanted.The patient was doing well following the procedure.

Manufacturer Narrative

A picture of the device following removal from the patient was provided for analysis.The picture shows the endoprosthesis with the stent wire separated from the device except for a single attachment point.The physician¿s observation that the deployment line became stuck could not be evaluated nor confirmed with the picture provided.The physician¿s observation that the stent began to unravel when attempting to retrieve the device is also consistent with the picture provided.Not enough information was provided to determine the cause of the reported event.A series of images from a tips procedure were received via powerpoint from a provider at (b)(6) ¿ university campus upon follow-up for evaluation.A total of seven (7) images and six (6) angiogram clips were sent for inclusion.A full imaging evaluation could not be performed as a result of images not meeting dicom® standard.The extent and accuracy of the observations and findings may be limited due to the completeness, format, and/or quality of the images provided for review.Gore cannot make conclusions or guarantee the images provided are complete, accurate, or lack alteration.Based on the imaging provided, a tips procedure with a right hepatic vein to right portal vein approach was performed.A gore® viatorr® device was introduced and the first step of deployment of the unlined region of the device had been completed.Additional imaging shows the unlined region of a gore® viatorr® device is deployed, and deployment of the graft-lined region was initiated with a large portion deployed while a small segment of the graft-lined region at the hepatic venous end remains constrained.The provider reported that ¿after pulling string with usual force¿ the viatorr® device remains undeployed and that ¿releasing the string with greater strength resulted in viatorr migrating cephalad, with hepatic venous end terminating in mid right atrium (not shown)¿, which cannot be evaluated nor confirmed with the imaging provided.The provider then reported upsizing the sheath to 16 fr, ¿followed by piecemeal removal¿ of the viatorr® device ¿with a rigid endobrochial forceps device.¿ further images show a viatorr® device being recaptured and resheathed into an introducer sheath, and the nitinol wire around the graft-lined region appears unraveled where the device has been reconstrained into the introducer sheath.It is not able to be determined by the available imagining at what point nor how the damage to the sinusoidal pattern of the nitinol wire frame occurred.Media images show a gore®viatorr® device inserted with the first step of deployment of the unlined region of the device completed.The viatorr® device is completely deployed in additional media imaging.Further images include a portal venogram and radiograph of a fully deployed viatorr® device.Based on the available information, this imaging evaluation can neither confirm the reported difficult deployment and migration of the initial viatorr® device nor determine a potential cause.Additionally, this imaging evaluation could not determine the events that occurred during the procedure based on the images received.The provided powerpoint file included two (2) follow-up ct scans that were taken on (b)(6) 2022.Cta reconstruction images appear to show an implanted device within what appears to be the hepatic the hepatic vein and the portal vein.A device marker can be visualized at the end of the device that is near the inferior vena cava and a partial radiopaque marker, probably part of the gold band of the device, can be visualized near the hepatic vein/portal vein bifurcation.The unlined portion of the stent appears to be in the portal vein.

• Brand Name: GORE® VIATORR® TIPS ENDOPROSTHESIS WITH CONTROLLED EXPANSION
• Type of Device: SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL PHOENIX 1 B/P; 32360 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: marci stewart ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 14775201
• MDR Text Key: 294541974
• Report Number: 3007284313-2022-01978
• Device Sequence Number: 1
• Product Code: MIR
• UDI-Device Identifier: 00733132635030
• UDI-Public: 00733132635030
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PTB8107275
• Device Catalogue Number: PTB8107275
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 85 KG